A Study of REGN2810 and Ipilimumab in Patients With Lung Cancer

NCT03430063 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2022-11-03

Study results available
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Summary

The primary objective of the study is to compare the objective response rate (ORR) of high dose cemiplimab (HDREGN2810) and standard dose cemiplimab plus ipilimumab combination therapy (SDREGN2810/ipi) to the ORR of standard dose cemiplimab (SDREGN2810) in the second-line treatment of patients with advanced squamous or non-squamous non-small cell lung cancer (NSCLC), in patients whose tumors express programmed cell death ligand 1 (PD-L1) in \<50% of tumor cells.

Conditions

  • Advanced Non-Small Cell Lung Carcinoma

Interventions

DRUG

SDREGN2810

Standard dose intravenous (IV) infusion

DRUG

SDREGN2810/ipi

Combination therapy dose IV

DRUG

HDREGN2810

High dose IV

Sponsors & Collaborators

Principal Investigators

  • Clinical Trial Management · Regeneron Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-29
Primary Completion
2021-10-27
Completion
2021-10-27
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • France
  • Germany
  • Poland
  • South Korea
  • Spain
  • Taiwan
  • United Kingdom

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03430063 on ClinicalTrials.gov